Additional consideration is necessary for enrollment of subjects who cannot consent for themselves; minors and cognitively impaired adults. This session will cover the requirements for obtaining informed consent from a Parent/Guardian or Legally Authorized Representative (LAR) as well as best practices for obtaining and documenting assent from subjects.
Other topics to be addressed include:
- Assessing capacity to consent
- Who has legal authority to provide informed consent for subjects who are not able to consent for themselves
- Procedures for obtaining consent when/if capacity to consent changes